FDA.reportPublic FDA data

Vichy Laboratoires Normaderm SOS Acne Rescue Spot Corrector

Manufacturer
L'Oreal USA Products Inc | Englewood Lab, Inc.
Effective date
2023-12-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:48

Label at a glance#

ProductVichy Laboratoires Normaderm SOS Acne Rescue Spot Corrector
Active ingredientSULFUR
Label structure11 sections

Dosage and administration

clean the skin thoroughly before applying this product cover the entire affected area with a thin layer one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION


Sulfur 10%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

  • broken skin
  • large areas of the skin

When using this product

OTC - WHEN USING SECTION

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • apply only to areas with acne

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, niacinamide, zea mays (corn) starch, glycolic acid, stearyl alcohol, glycerin, octyldodecyl myristate, cetearyl alcohol, glyceryl stearate, sodium hydroxide, magnesium aluminum silicate, PEG-100 stearate, c13-14 isoparaffin, allantoin, ceteareth-20, phenoxyethanol, phenylethyl resorcinol, tocopheryl acetate, disodium EDTA, laureth-7, hydrogenated lecithin, polyacrylamide, ethylhexylglycerin

Questions or comments?

OTC - QUESTIONS SECTION

1-877-378-4249

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

image of a carton
image of a carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240725sulfur 10 % Topical LotionPSN3
240725sulfur 100 MG/ML Topical LotionSCD3
240725sulfur 10 % Topical LotionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-648-01Vichy Laboratoires Normaderm SOS Acne Rescue Spot Corrector1 in 1 CARTONLOTION13
49967-648-01Vichy Laboratoires Normaderm SOS Acne Rescue Spot Corrector20 mL in 1 TUBELOTION203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-648VICHY LABORATOIRES NORMADERM SOS ACNE RESCUE SPOT CORRECTOR (SULFUR) LOTION [L'OREAL USA PRODUCTS INC]3Current NDC, Legacy NDC, 2 package rows20231228_4907bc52-62e3-4256-b4ca-bcde896a4aab.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-64849967-648-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULFUR70FD1KFU70ACTIB
WATER059QF0KO0RIACT
NIACINAMIDE25X51I8RD4IACT
STARCH, CORNO8232NY3SJIACT
GLYCOLIC ACID0WT12SX38SIACT
STEARYL ALCOHOL2KR89I4H1YIACT
GLYCERINPDC6A3C0OXIACT
OCTYLDODECYL MYRISTATES013N99GR8IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SODIUM HYDROXIDE55X04QC32IIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
PEG-100 STEARATEYD01N1999RIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
ALLANTOIN344S277G0ZIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PHENYLETHYL RESORCINOLG37UFG162OIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE DISODIUM7FLD91C86KIACT
LAURETH-7Z95S6G8201IACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
NYLON-12446U8J075BIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vichy Laboratoires Normaderm SOS Acne Rescue Spot CorrectorSULFURL'Oreal USA Products Inc4907bc52-62e3-4256-b4ca-bcde896a4aab2023-12-27WarningsExact identifier
ndc (package): 49967-648-01
ndc (product): 49967-648
ndc11 (package): 49967064801
spl id: 1f025bc8-9065-4b47-92f0-04b498707531
spl set id: 4907bc52-62e3-4256-b4ca-bcde896a4aab

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.